The approval allows Datroway to be used as a first-line treatment for adults with unresectable or metastatic TNBC who cannot receive programmed cell death protein 1 (PD-1) or PD-L1 inhibitor therapy.
This is said to be the first approval of a TROP2-directed antibody drug conjugate (ADC) in this patient group.
Earlier, the FDA granted priority review for Datroway based on data from the TROPION-Breast02 Phase III trial.
In this trial, Datroway achieved a significant improvement in median overall survival (OS), extending survival by five months compared to chemotherapy.
The trial reported a 43% reduction in patients’ risk of disease progression or death and an objective response rate (ORR) of 64% compared to 30% with chemotherapy. The safety profile of Datroway matched that of earlier breast cancer trials.
This application was reviewed under Project Orbis, which allows for synchronised submissions to health authorities in Canada, Australia, Switzerland, and Singapore. Reviews continue in Japan, China, and the EU.
Datroway was discovered by Daiichi Sankyo and is being developed and commercialised in partnership with AstraZeneca.
AstraZeneca oncology haematology business unit executive vice-president Dave Fredrickson said: “Triple-negative breast cancer is notoriously difficult to treat. Patients with metastatic disease, especially those who are unable to receive immunotherapy, urgently need more effective, durable and tolerable treatment options, which extend survival.
“With today’s approval, we are proud to bring Datroway to a broad population of advanced triple-negative breast cancer patients and we continue to study its promise as a mainstay treatment across tumours, stages and settings.”
Earlier this month, Daiichi Sankyo entered a collaboration with France-based Waiv, which aims to lead digital pathology biomarker discovery for an ADC programme.